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    Summary
    EudraCT Number:2007-002495-34
    Sponsor's Protocol Code Number:GETUG 17/0702
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-002495-34
    A.3Full title of the trial
    Etude randomisée multicentrique comparant une radiothérapie adjuvante immédidate associée à une hormonothérapie courte par analogue LH-RH (Décapeptyl LP®) vs une radiothérapie différée à la rechute biochimique associée à une hormonothérapie courte par analogue LH-RH (Décapatyl LP®) chez les patients opérés d'un cancer de la prostate pT3 R1 pN0 ou pNX, de risque intermédiaire
    A.3.2Name or abbreviated title of the trial where available
    NON APPLICABLE
    A.4.1Sponsor's protocol code numberGETUG 17/0702
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNON APPLICABLE
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFNCLCC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DECAPEPTYL® LP
    D.2.1.1.2Name of the Marketing Authorisation holderBEAUFOUR IPSEN Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDECAPEPTYL® LP
    D.3.2Product code NON APPLICABLE
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriptoréline (pamoate exprimé en triptoréline)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11,25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    L’étude s’adresse aux patients opérés par prostatectomie radicale pour un cancer de prostate pT3 R1 pN0 ou pNx et avec un PSA post-opératoire indosable. Elle vise à comparer l’efficacité sur la survie sans évènement d’un traitement adjuvant post-opératoire systématique par hormonothérapie courte et radiothérapie de la loge de prostatectomie au même traitement délivré au moment de la récidive biochimique (0,2 ng/ml < PSA < 2 ng/ml).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.2Term Adenocarcinoma of prostate
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L'objectif principal est de comparer l’efficacité d’une radio-hormonothérapie immédiate après prostatectomie pour lésion pT3 R1 pN0 ou pNX au même traitement donné en situation de récidive biochimique sur la survie sans événement à 5 ans. L’événement d’intérêt est défini par la survenue d’une progression clinique et/ou biochimique documentée ou d’un décès. La survenue d’une première récidive biochimique isolée dans le bras A « traitement différé » ne sera pas considérée pas comme un événement puisque conditionnant la mise en place de la stratégie thérapeutique : radiothérapie + hormonothérapie différée.
    E.2.2Secondary objectives of the trial
    – Evaluer la survie globale
    – Evaluer la survie spécifique sans métastase
    – Evaluer les toxicités aiguës et tardives
    – Evaluer la qualité de vie
    – Evaluer la dépendance fonctionnelle chez les patients > 75 ans.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Etude d'évaluation de la qualité de vie par auto-questionnaire
    - Etude d'évaluation de la dépendance fonctionnelle chez les patients agés de plus de 75 ans (2 ans après la fin de la radiothérapie par auto-questionnaire).
    E.3Principal inclusion criteria
    1) Patient traité par chirurgie exclusive pour un adénocarcinome prostatique localisé,
    2) pT3a pT3b (ou pT4 par atteinte du col vésical) et R1,
    3) Taux de PSA ≤ 0,1 ng/ml après la prostatectomie (dosage à 1 mois confirmé),
    4) Patient pouvant être traité dans les 6 mois suivant la chirurgie,
    5) Présence de marges positives (présence des glandes tumorales au contact du contour encré) sur la pièce opératoire,
    6) Patient pN0 ou pNx : curage ganglionnaire au moment de la prostatectomie négatif ou absence de curage ganglionnaire,
    7) Patient sans aucun signe clinique ou biochimique de maladie évolutive,
    8) Patient âgé de plus de 18 ans avec une espérance de vie ≥ 10 ans,
    9) Performance status ECOG = 0 ou 1,
    10) Affiliation à un régime de sécurité sociale,
    11) Patient ayant reçu l’information et ayant signé un consentement éclairé.
    E.4Principal exclusion criteria
    1) Patient ayant un cancer de la prostate d’histologie autre qu’adénocarcinome
    2) Patient avec un Gleason 8 et avec atteintes des vésicules séminales
    3) Patient pN1 : envahissement ganglionnaire prouvé histologiquement lors du curage initial,
    4) Patient pT2,
    5) Castration chirurgicale ou chimique,
    6) Patient ayant eu un traitement antérieur par hormonothérapie,
    7) Pas de traitement par radiothérapie dans les 3 Mois suivant la prostatectomie radicale,
    8) Patient ayant des antécédents de radiothérapie pelvienne,
    9) Antécédents de cancer (sauf un épithélioma baso-cellulaire cutané) ayant récidivé dans les 5 années précédant la chirurgie,
    10) Patient présentant une hypertension artérielle grave non contrôlée par un traitement adapté (≥ 160 mm Hg en systolique et/ou ≥ 90 mm Hg en diastolique),
    11) Patient ayant une hypersensibilité connue à la GnRH ou à ses analogues,
    12) Contre indication aux IM (Intra musculaire),
    13) Patient déjà inclus dans une autre étude interventionnelle ayant nécessité l’accord d’un CPP, 14) Personnes privées de liberté ou sous tutelle ou Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est la survie sans événement, calculée de la date de randomisation jusqu’à la date de première mise en évidence d’une progression documentée ou jusqu’à la date de décès quelle qu’en soit la cause, ou jusqu’à la date de dernières nouvelles (données censurées). La survenue d’une première récidive biochimique pure dans le bras A (traitement différé), récidive définie par un taux de PSA >0.2 ng/ml et < 2 ng/ml, ne sera pas considérée comme un événement puisque conditionnant la mise en place de la stratégie thérapeutique « radiothérapie + hormonothérapie différée ».
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    RT+ Décapeptyl à récidive vs RT+Décapeptyl juste après chir
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state718
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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